ArticlemAbs
Multi-attribute Raman spectroscopy (MARS) for monitoring product quality attributes in formulated monoclonal antibody therapeutics.
Article in mAbs. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Who cites it
13 citing papers in PubMed, 31 citations in OpenAlex.
- Using mass spectrometry for robust identity release testing in a global quality control network.mAbs · 2026Article
- Development and Integrated Application of the Multi-Attribute Method (MAM) in Quality Control of Biotechnological Drugs.Biotechnology and bioengineering · 2026Review
- Automated high-throughput Raman detection of fluidic samples: measurement setup and methods preventing air bubble interference.Analytical and bioanalytical chemistry · 2026Article
- Current Trends in In Vitro Diagnostics Using Surface-Enhanced Raman Scattering in Translational Biomedical Research.Biosensors · 2025Review
- Raman-based PAT for multi-attribute monitoring during VLP recovery by dual-stage CFF: attribute-specific spectral preprocessing for model transfer.Frontiers in bioengineering and biotechnology · 2025Article
- Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics.Journal of pharmaceutical analysis · 2024Review
- Generative data augmentation and automated optimization of convolutional neural networks for process monitoring.Frontiers in bioengineering and biotechnology · 2024Article
- Raman-based PAT for VLP precipitation: systematic data diversification and preprocessing pipeline identification.Frontiers in bioengineering and biotechnology · 2024Article
- Comprehensive modeling of cell culture profile using Raman spectroscopy and machine learning.Scientific reports · 2023Article
- Application of Raman Spectroscopy to Dynamic Binding Capacity Analysis.Applied spectroscopy · 2023Article
- Monitoring of ultra- and diafiltration processes by Kalman-filtered Raman measurements.Analytical and bioanalytical chemistry · 2023Article
- Article
- Mechanistic deconvolution of BSA size variants by constrained Raman pseudo-Voigt hard modeling during anion-exchange chromatography.Biotechnology progressArticle
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Authors and funding
26 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Rapid release of biopharmaceutical products enables a more efficient drug manufacturing process. Multi-attribute methods that target several product quality attributes (PQAs) at one time are an essential pillar of the rapid-release strategy. The novel, high-throughput, and nondestructive multi-attribute Raman spectroscopy (MARS) method combines Raman spectroscopy, design of experiments, and multivariate data analysis (MVDA). MARS allows the measurement of multiple PQAs for formulated protein therapeutics without sample preparation from a single spectroscopic scan. Variable importance in projection analysis is used to associate the chemical and spectral basis of targeted PQAs, which assists in model interpretation and selection. This study shows the feasibility of MARS for the measurement of both protein purity-related and formulation-related PQAs; measurements of protein concentration, osmolality, and some formulation additives were achieved by a generic multiproduct model for various protein products containing the same formulation components. MARS demonstrates the potential to be a powerful methodology to improve the efficiency of biopharmaceutical development and manufacturing, as it features fast turnaround time, good robustness, less human intervention, and potential for automation.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.